Question about the Materials section of the Technical File

[rdavis_esd]

The product I am documenting is an electronic device contained in a metal enclosure. What should be listed in the Materials section of the technical file, all the materials used to construct the device?

The enclosures are ordered from another vendor. We supply them with drawings and they ship us a steel enclosure. Do I need to list the composition of steel used in the manufacture of the enclosure? What about the composition of the nuts and bolts that go into building the enclosure?

The electronics are built using RoHS parts, lead-free solder, and PCBs made using a lead-free process.

I assume the purpose of the Materials section is to certify that the entire product adheres to the RoHS directive. Is it sufficient to state that our process of manufacturing is free of the restricted substances (lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE))?

[hazu]

Richard, do you use bills of materials? Probably there all materials are listed.

It is important to have a good understanding of all the materials. Like in your example, the steel should be of a certain quality in order to be suitable for the intended purpose of the machine. Therefore it is necessary to have information about the materials in the Technical File.

[rdavis_esd]

Yes, we use bills of material. Perhaps our BOMs are not as detailed as they should be.

I suppose I'm having a difficult time wrapping my head around the idea that I would need to know the molecular composition of everything inside this product, down to the materials used in the wire, the materials used inside the integrated circuits that go on the PCB, etc.

When I'm presenting this information in the technical file, what's the best way to do it? List the item on the BOM, the part number, and what its made of?

[hazu]

Its not about going to the molecule level. Its about answering the question whether the material is fit for its purpose.

For example, the plastic used to make the insulation of the wiring: what temperatures is it able to withstand before it starts melting? Is this a temperature that will not be reached in normal and foreseeable conditions of use?